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Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks

Langan, Sinéad M.; Stuart, Beth; Bradshaw, Lucy; Schmitt, Jochen; Williams, Hywel C.; Thomas, Kim S.

Authors

Sinéad M. Langan

Beth Stuart

Lucy Bradshaw

Jochen Schmitt

Hywel C. Williams

Kim S. Thomas



Abstract

Background:Because atopic dermatitis (AD) is a relapsing, remitting disease, assessing long‐term control is important. Well controlled weeks (WCWs) have been used to assess asthma long‐term control, but never validated for AD.
Objectives: To assess feasibility, validity and interpretability of WCWs in AD patients.
Methods: Three studies of patients with moderate‐to‐severe AD including 4‐6 months of daily/weekly symptom and treatment use data were evaluated (Study A: n=336; Study B: n=60; Study C: n=224). WCWs were defined by worsening symptoms and increased medication use. Feasibility, construct validity and interpretability of WCWs were determined by assessing missing data, association with validated AD outcomes, and floor/ceiling effects. Analysis used linear and logistic regression.
Results: WCWs were feasible to collect ‐ 95.2% (study A) and 94.7% (study B) contributed data for at least half of the weekly data‐points, and 93.2% and 88.7% contributed to all data‐points up to 4 months. WCWs were significantly associated with validated AD severity instruments including patient-reported (POEM) and objective signs (EASI, TIS and SASSAD). The odds of experiencing a WCW if AD severity was clear/mild was 5.8 (95% confidence interval (CI) 3.5 to 9.7), 1.9 (95%CI 0.8 to 4.4) and 8.1 (95%CI 4.5 to 14.6) in Studies A, B and C, respectively. WCWs were associated with ceiling effects‐ 31.6% (study A) and 37.5% (study B) of participants had no WCWs for >90% of the time.
Conclusions: WCWs are valid and feasible for measuring long‐term control in AD trials. However, ceiling effects and burden of data collection may limit use.

Journal Article Type Article
Publication Date 2017-12
Journal Journal of Allergy and Clinical Immunology
Print ISSN 0091-6749
Electronic ISSN 1097-6825
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 140
Issue 6
Pages 1580-1586
APA6 Citation Langan, S. M., Stuart, B., Bradshaw, L., Schmitt, J., Williams, H. C., & Thomas, K. S. (2017). Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks. Journal of Allergy and Clinical Immunology, 140(6), 1580-1586. https://doi.org/10.1016/j.jaci.2017.02.043
DOI https://doi.org/10.1016/j.jaci.2017.02.043
Keywords AD, long‐term control, outcome measures
Publisher URL http://www.sciencedirect.com/science/article/pii/S0091674917306772
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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